Status
Ongoing
Drug Enforcement D-0365-2025
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
Classification
Class I
Report Date
April 23, 2025
Termination Date
—
Product Information
- Product description
- Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma Limited, Hyderabad, - 500 043 INDIA, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-636-52
- Product quantity
- 4,010 bags
- Reason for recall
- LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
- Recall initiation reason
- —
- Initial firm notification
- —
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Address
-
107 College Rd E
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0365-2025
- Event ID
- 96470
- Recall initiation date
- March 13, 2025
- Center classification date
- April 16, 2025
- Code info
- Lot: A1540076, Exp 08/31/2026
- More code info
- —